Thursday, October 07, 2010

Defensive Blogging

That's why, until I hear from the editor of Europace, A. John Camm, MD (whom I e-mailed last evening) about why a case report published in their journal and reported by me was retracted, I have decided to bring down my blog post. The case was about a recent Biotronik 340 VR-T implantable cardiac defibrillator (ICD) battery failure that ruptured the device, injuring a patient. In that post, I published a portion of the figure from the case report with a link citing the reference. The pictures were dramatic.

But like an X-rated movie, for some, they might be too dramatic.

That's why today I've decided to practice something I rarely do - defensive blogging - and brought down the post. The ramifications of those photos to the multi-billion dollar medical device industry were simply too compromising - for them and me.

Perhaps more importantly, we should ask ourselves how far we've gotten with the whole issue of device failure reporting to the public. Ever since the 2005 published report in the New York Times about Guidant's failure to disclose flaws in its line of Prism defibrillators, the industry has worked hard to improve its image on how adverse device events are reported. Large websites and complicated trade-marked systems have been put in place to better quantify when a device "advisory" should be issued to the public in conjunction with the FDA.

And now this - a horrible, unusual and exceedingly rare single case of an ICD battery failure from a device that was supposed to just sit there and prevent sudden cardiac death splashed all over the Internet.

Hard to put those pictures in perspective to the over 250,000 patients have had these devices implanted with numerous lives saved as a result.

You never hear about the saves.

But the real reason this case was so important is that we now see that one set of photos is probably worth thousands of safety databases and there's not too much any group of engineers or doctors can do to change that reality.

18 comments:

I think the real issue here is why the report was withdrawn by Europace (if that is what has in fact happened).

As your job is to comment on the news, without the resources to report, you have done what is responsible. For all you know at this time, the report may not even be accurate.

I expect, in time, we'll find out what is going on. If Europace is suppressing the story to minimize it's impact on the industry, then I would say this is terribly unfortunate. If we cannot report matters such as this in peer reviewed professional journals, we're in big trouble. This would not excuse sensationalized lay press coverage, which, thankfully, appears not to have occurred.

I hope you'll keep us informed and report what's going on at Europace. That story may be ultimately more troubling and indefensible than the actual case report. Without the ability to report such tragedies, what can we do to prevent them in the future?

I contacted Dr. Martin Hudec by e-mail (the corresponding author on the retracted case report) and he was kind enough to send on this explanation his retraction from Europace. Hopefully this will help clarify the circumstances and findings of this case report. I have included his reponse here:

Dear Dr Fisher,

thank you for your e-mail and your interest in the case. I can confirm I have withdrawn my case report voluntarily after I have received new important information. I plan to resubmit this interesting case in Europace soon.What I see happening is some kind of media sensation being created without the facts. This concerns me because my only intention was to share a rare experience that would hopefully help my colleagues to more fully understand the possible complications that can occur, even if rarely, with such complex technology.

So, please allow me to give you the information that you are missing.

The term "explosion" is not accurate. After talking to engineers the more appropriate word would be 'venting' of the battery. The shape of ICD was distorted, but not ruptured in any way.

Furthermore, I have described what I believed was the first such a complication published, there are more reports about battery overheating which I got to my hands but not published in medical journals. These malfunctions are extremely rare and very unfortunate, however any device from any manufacturer could and has had such complications.

This information is important to put the report into the appropriate context.

Regarding the concerns people have about this patient, he is doing okay. The X-rays were taken before the procedure as well as clinical findings of subcutaneous emphysema so it occured most likely during battery / ICD venting. Of course this was not a good experience for my patient, no complication is ever good, but the device is explanted and he is recovered from the procedure.

We are implanting our patients with highly advanced devices that save millions of lives around the world. You know that the technology is intricate and complex, and every company has to comply with very tough regulations and clinical research before it can be released. This was a singular event, and I do not agree that all the negative discussion around these devices is appropriate. I hope that you will consider using your influence to correct this.

As an additional comment I would like to point out that EUROPACE magazine is comprised of a highly esteemed editorial board, including Chief-Editor of EUROPACE, the renowned Professor John Camm. Professor Camm and I have discussed this situation, and he fully supports the conclusion that the inaccuracies in the case report require the withdrawal.

The EP who wrote the report seems mostly concerned with changing the term "exploding" to "venting." But if a picture is worth anything, I'll keep "explosion," thanks. It looks like an explosion, and I sure bet it quacked like an explosion.

We shouldn't worry! It's like porn! Neither one of you wants to hurt the industry! so we take it all back! -- is that your message?

The pit in your stomach was caused by what? A fedex envelope from Biotronik's lawyer? I read your blog religiously and my father is your patient. I do not think that you were wrong to post these pictures or the story. Biotronik has put some extreme pressure on this doctor in a manner that would not be tolerated in the USA. A foreign company such as that is not subject to the same corporate integrity as American companies. This should be looked into by the FDA as a cover up in Europe is easy top perform outside their jurisdiction. Maybe they shouldn't be allowed to sell devices in this country.

It doesn't appear as though Biotronik is running away from the story. I think a few things should be cleared up. One being that this isn't the first time this has happened. Apparently, it has occured with other companies and it has occured on more than one occasion.

Why does Bio get beat up so much over this? I know that in my community Bio has done a stand-up job and has a top notch team in place. I have never had a problem with their products, coverage... nothing. In fact, MDT and BSX have caused me much more grief in the past few years then Bio ever has.

Lets not forget 7-8 years ago with one of "the big three"'s battery recall. A very publicized recall where very few devices 'shorted' but many many were changed out, inherently exposing patients to risks of infection. It sounds like the same thing occurred in the Biotronik battery, lithium gases building up, deforming the dielectric, creating a short, and manifesting as a "very hot potato". The difference is this one came with pictures.

In my opinion, these things are man-made and occasionally fail....sometimes spectacularly. But this class of devices, the ICDs, frequently and spectacularly save lives.

Hello, you are correct, and I owe you a sincere apology for my tone, which was inappropriate. I do not doubt, and have no right to doubt, your intentions.

Though not to justify, but explain,my response, in part I believe I was reacting to the Europace EP's comments to you, and to your own subsequent anxieties about publishing a simple and true photograph. The Europace EP does not actually retract any of the facts; he only wants to restate the context, replace the term "explosion" with "venting," and remind us (true) that it could happen with any manufacturer's device. He meant in his article to address "colleagues," not ICD users, and he believes, apparently, and truthfully you appear to as well, that we could never understand these "highly advanced devices" well enough not to wrongfully engage in "negative discussions." And, in fact, he did not report, in his original case study, on the individual's outcome. That individual is now "okay" and "recovered." Whatever that means.

In some ways, EPs and ICD users, to me, seem to exist in different realities. I think I was just "venting," not "exploding." My feelings were "distorted," but not "ruptured."

(p.s. those last sentences honestly are just for fun, and no insult intended, honestly.)

Thank you for providing an interesting an informed forum, and best wishes.

No matter how this gets sliced, it still has the pungent smell of burnt flesh.

As an ICD patient and strong patient advocate, I felt that I had to look further into this. So, I posted it to the Facebook Page of Biotronik Brazil with a request for an explanation. The wall post was quickly removed and the page settings were changed to prevent outsiders from posting links.

So much for engagement. LOL. Industry has a long, long way to go to understand how social media works. Please know that I'm not going away. I am taking the ICD with me to the grave. It is a life time commitment. Engagement is your only choice.

Dr. Wes, FYI, the blog post with photos is available on the Google cache with a search: Dr. Wes EuropaceUnfortunately, the search engine spiders are likely to hit anything on the web before it can be removed.Bill GraneyCollegeville, PA

Wes,, this is not an uncommon problem for physicians who report an untoward event about devices or improper use of devices. I had a similar event with an ophthalmology device that was being used improperly for refractive surgery. It got me fired since I was an employee in this particular practice. The short of it was the surgeon who was doing the procedure was notified that I had been interviewed by an ophthalmology publication regarding the device and the procedure...Our surgeon (my boss) knew of the untoward outcomes, which were many. The manufacturer (Chiron) called my employer and asked what was going on. He denied any problems with the procedure and was peforming 20 of these/week. Two days later I received a termination letter. Bottom line....follow the money. These are powerful people who at times have no scruples. I congratulate you....don't back down. End of story...there was a class action lawsuit by 60 patients agains the surgeon, he lost...also lost his business and surgery center. Regardless of the rarity of this event, patients deserve to make a decision for themselves. Don't fool around here..get a good letter from an attorney and dispute their actions. Document all of this for any possible future events. They may wind up suing you for libel ....

I'm glad the article was pulled. Hysteria -- which I'm willing to classify the use of "explosion" as being -- serves no purpose well. Further is the risk that other entities responding to this report would place restrictions on we ICD patients, since "That thing might explode!" Life would become far more complex, and annoying.

Granted, here's hoping if there is a problem with venting it's resolved, quickly, but in all cases in the measured, assured manner of effective medical research, and not by turning device issues into tabloid/hysteria fodder.

Ugh. You report on a medical device failure that caused some harm to the patient. Now you are VERY concerned about the harm being done to the manufacturer whose devices have saved many thousands of people from premature death. I'm a patient. I'd rather know that on very rare occasions the divice can "rupture". It's called full disclosure - transparency. I don't want to go back to the bad old days when the patient was "protected". And I certainly don't want a press that is censored. (Perhaps too heavy a point, but you can get there from here.)

No one should be attacking Dr. Wes for his removal of the story. He was simply looking to protect himself. After Europace removed the story for a reason I am sure we can all ascertain, he was left exposed. He could not be the only source on the web for this information. Sooooo, he had no choice but to remove it. It was Europace and Biotronic that have acted in a manner that is indicative of a subversive coup. The truth is is that the story is out there, it happened and no matter what Biotronic tries to do cover it up it will continue to resurface.

AbstractA 79-year-old man with a pectoral implantable cardioverter defibrillator (ICD) system underwent periodic defibrillation threshold testing 18 months after implant. Attempted delivery of a 15-J shock caused a light flash above the pocket and a loud "pop." High-voltage lead impedance was <20 ohms. Pocket exploration revealed insulation abrasion of the high-voltage portion of the single-coil right ventricular lead. The outer shield of the active can pulse was perforated and scorched due to arcing. Device analysis confirmed a shorted transistor in the high-voltage output circuit. Unsuspected physical contact between high-voltage electrodes of opposite polarity within the pocket can cause catastrophic ICD system failure.

I am curious, who's ICD was implanted in the aforementioned patient in Boston? I think it a bit suspicious when one company is singled out for an anomaly and not others. This incident, although exceedingly rare, has happened to other manufacturer's devices. Please understand that there is a reason that anything man-made comes with a Warranty and not a Gurantee. There is no way to 100% predict what will happen to a device once implanted. However, each company, to the best of my knowledge, stands behind their products and do all they can to avoid patient injury.

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About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.